The benchtop FMS-Pressure/Moisture Headspace Analyzer can be utilized throughout the product lifecycle for development and QC laboratory applications, as well as final inspection of headspace moisture and pressure levels in production and packaging.

Nominal Specifications

Physical and Electrical

Dimensions (WxDxH): 30.5 x 30.5 x 29.2 cm (12” x 12” x 11.5”)

Weight: 13.6 kg (30 lbs)

Power Requirements: 110-240 VAC, 50/60 Hz, 60 W

Controller: PC

FMS Software Package

Data Integrity and Compliance

To meet the current regulatory requirements on data integrity, the FMS Software Package includes a GxP mode to support the collection of compliant analytical data while limiting the need for procedural controls.

Software Features

All FMS systems are provided with the basic software package. This includes different operating modes allowing the performance of measurements that do and do not require strict compliance.

For enhanced compliance features and centralized data management, the additional GxP Database Package is available. Some main features:

Install Options

The FMS benchtop headspace analyzers are installed by a LIGHTHOUSE Application Engineer with the following support:

System qualification (IQ/OQ)

User training and system start-up support

Performance testing

Validation Protocols

LIGHTHOUSE offers a complete set of validation protocols, as well as on-site validation services designed to assist customers in their validation efforts of LIGHTHOUSE systems. The validation documentation can be modified to fit a customer’s particular document format standard.

TESTIMONIALS

"At Gilead we use Lighthouse’s FMS benchtop headspace moisture/pressure analyzer to nondestructively confirm the integrity of developmental and investigatory vials. We use their high speed VISTA platform at the production level to confirm that 100% of inspected product is integral before it ships."

Tark Bunch

Senior Research Scientist at Gilead Sciences, USA

"We are studying the correlation of headspace moisture and product moisture in lyophilized products to see if this can be a good predictor to find an atypical/moist vial in a lot population. The team at Lighthouse are very knowledgeable and have been very helpful getting us up and running."

Tark Bunch

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